We have recently seen reports about the unbelievable amount of pressure on the NHS, including inaccessibility to GPs; a high degree of emergency admissions; and bed-blocking within hospitals where vulnerable patients cannot be discharged safely. These factors have exacerbated the pressure on our healthcare system to almost unprecedented levels. Medical technologies or MedTech could be the way forward to ease some of the pressure ...
The U.S. Department of Justice’s Office of Legal Counsel recently released an advisory opinion[i] regarding Section 1461 of title 18 of the U.S. Code. In it, they write the “Comstock Act”[ii] does not prohibit the mailing of certain medications used to perform abortions where the sender does not believe the medications will be used unlawfully. This opinion comes in the wake of the U.S ...
As the Covid-19 Inquiry reaches Module 2 of its timeline and it turns its attention to the political and administrative decisions made at the height of the pandemic, Shoosmiths looks at the history of public inquiries to reflect on their purpose and effectiveness in preventing future mistakes of the same kind. Reviewing previous public inquiries may inform us about the likely trajectory of the Covid-19 Inquiry ...
Hemp seeds have been eaten in the EU for a long time. The seeds may contain trace amounts of tetrahydrocannabinol (THC) because this cannabinoid is a natural constituent of the cannabis plant from which the seeds originate. The EU regulator has decided to harmonize the maximum levels for THC in hemp seeds throughout the Union within the food contaminants framework. Commission Regulation 2022/1393 of 11 August 2022 amends the annex to Regulation No1881/2006 on food contaminants to this effect ...
On December 14, 2022, the National Labor Relations Board reinstated a previous test used to determine which employees must be included in an appropriate bargaining unit. In American Steel Construction, Inc., 372 NLRB No. 23 (2022), the Board overruled the test established in PCC Structurals, 365 NLRB No. 160 (2017), and The Boeing Co., 368 NLRB No. 67 (2019), opting to return to the test set forth in Specialty Healthcare & Rehabilitation Center of Mobile, 357 NLRB 934 (2011) ...
As applications for Module 3 Core Participant (CP) status drew to a close on 5 December 2022, the Inquiry team have announced two key dates, as we continue to monitor progress of the UK Covid-19 Inquiry. No timescales have been given as to when applicants will be informed of the outcome of their CP applications, with the only information provided being that the Inquiry Chair (Baroness Heather Hallett) will be reviewing and determining in 'due course' ...
December 2, 2022 By: Anna G. Thomas To increase transparency regarding payments to physicians by drug and medical device companies, Governor Newsom signed AB 1278, which imposes certain additional disclosure obligations on physicians. Beginning on January 1, 2023, physicians will be required to comply with new patient notice and posting requirements. Notice to Patients Under this law, physicians must provide to patients an Open Payments database notice ...
The UK Covid-19 Inquiry (“the Inquiry”) opened its third Module on 8 November 2022, along with the application process for Core Participant (“CP”) status. Module 3 will consider the impact of the Covid-19 pandemic on the healthcare sector in England, Wales, Scotland and Northern Ireland ...
On November 15, 2022, Governor Andy Beshear announced two executive orders related to cannabis in Kentucky. The first executive order allows certain individual Kentuckians and their caregivers to bring and use medical marijuana into the state without facing legal consequences beginning January 1, 2023, so long as they meet a set of three criteria ...
As the regulation system on human genetic resources ("HGR"), biosecurity and laboratory animals is experiencing continuous improvement, enforcement actions of the Ministry of Science and Technology ("the MOST") have become more active and tight in recent years ...
On appeal, the trademark infringement was no longer in dispute. Still, the decision has a fundamental interest in the intellectual property legal space. The judgement deals with principal issues related to compensation claims for trademark infringement where the infringement and alleged damage merely relates to a subpart of the infringer’s ads and turnover. Norgesgjerde and Vindex (the original plaintiffs) claimed total damages and compensation in excess of NOK 10 million ...
Fast-growing e-commerce has changed lifestyles and invented new ways of consumption, amid which demand has rapidly increased for Internet-based medical services such as online drug sales and online medical diagnosis. Since the regulation and promotion of "Internet-based healthcare services" was included as part of the Outline of the "Healthy China 2030" Plan, China's Internet healthcare industry has been flourishing, channeled by a series of favorable policy decisions ...
Since 2013, the National Medical Products Administration ("NMPA")Center for Drug Evaluation("CDE")has been releasing a Drug Review Annual Report ("Report")each year, which summarizes its work on drug review of the previous year ...
How can an employment disciplinary investigation findings determine fitness and propriety? Senior Managers & Certification Regime (SM&CR) firms are under a duty to consider fitness and propriety on an ongoing basis ...
The Indonesian Minister of Health has issued Minister of Health Regulation No. 24 of 2022 on Medical Records (“MOH 24/2022”), under which the MOH requires all healthcare facilities to keep electronic medical records. MOH 24/2022 allows, among other things, cooperation between a healthcare facility and a third-party electronic organizer and covers who may have access to electronic medical records ...
On December 3, the U.S. Patent and Trademark Office (“USPTO”) will make a major change to how it processes trademark applications, which is anticipated to affect filing strategies, work flow, and even budgets. Brand owners in the U.S. might be wondering what they need to know about the Trademark Modernization Act’s (“TMA”) shortened office action response deadline ...
On October 26, 2022, the National Medical Products Administration ("NMPA") issued the newly revised Measures for the Administration of Drug Recalls ("the 2022 Measures") that has just been formally adopted. The former Measures for the Administration of Drug Recalls ("the 2007 Measures") was issued and implemented on December 10, 2007 ...
We are glad to present you a current digest of the most significant bills, regulatory changes, and measures affecting the pharmaceutical and healthcare industry for the period from June to October 2022. Follow the link to download the digest. ALRUD_Newsletter_Key_changes_in_Life_Sciences_for_the_June-October_2022_period_upd ...
October is Breast Cancer Awareness Month, an annual campaign to raise awareness about the impact of breast cancer and to raise funds for research into its cause, prevention, diagnosis, treatment and cure. The firm held an event last week at its offices with staff in order to raise awareness about breast cancer and to raise funds for the cause. The firm is once again making a contribution to the Action for Breast Cancer Foundation ...
On 13 October 2022, Shoosmiths hosted a webinar on the UK Covid-19 Inquiry (the ‘Inquiry’). The webinar took a closer look at the structure and progress of the Inquiry, alongside the commercial and legal considerations that any potential witness or party should be aware of, including the role of a Core Participant (‘CP’). The webinar was hosted by Paul Eccles (Partner) and included talks by Alex Friston (Associate) and Charles Arrand (Partner) ...
In February of 2022, during his State of the Union Address, President Biden announced an action plan to improve the safety and quality of care in the nation’s nursing homes.[i] On October 21, 2022, Centers for Medicare and Medicaid Services (CMS) announced new requirements to help with oversight of facilities selected to the Special Focus Facilities (SFF) Program ...
On the occasion of Breast Cancer Awareness Month 2022, our firm organized a photo-taking session on Friday, October 21 at 3 pm. This session is a part of a global effort to raise awareness about breast cancer, one of the world’s most prevalent types of cancer. Often times, the disease has been overlooked by males. However, breast cancer can affect both men and women ...
On December 7, 2021, in Georgia v. Biden, Case No. 1:21-cv-163, a federal district court judge in the U.S. District Court for the Southern District of Georgia issued a preliminary injunction enjoining enforcement of the COVID-19 vaccine mandate for federal contractors and subcontractors in all covered contracts in any state or territory of the United States. This injunction was nationwide applied to all federal contractors ...
In June 2022, at one of the annual meetings of the Employment, Social Policy, Health and Consumer Affairs (“EPSCO”) Council, health ministers expressed their concerns regarding the legislative transition to Regulation (EU) No 2017/745 of the European Parliament and of the European Council of 5 April 2017 on medical devices (“MDR”) and to Regulation 2017/746 of the European Parliament and of the European Council of 5 April 2017 on in vitro diagnostic medical devi
